FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL
MDR report key: 1820648
·
Received September 13, 2007
Report
- Report Number
- 1527736-2007-06064
- Event Type
- Malfunction
- Date Received
- September 13, 2007
- Date of Event
- June 29, 2007
- Report Date
- July 5, 2007
- Manufacturer
- ETHICON ENDO SURGERY, INC (CINCINNATI)
- Product Code
- FZP
- PMA / PMN Number
- K864102
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DAMAGED JAWS. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT WAS RETURNED WITH THE JAWS OVER TWISTED. THE INSTRUMENT WAS CYCLED AND EJECTED THE REMAINING CLIPS DUE TO THE CONDITION OF THE JAWS. THE INSTRUMENT LOCKED OUT AS INTENDED. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE ROOT CAUSE OF THE FINDING. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE GUN WAS FIRING SIDEWAYS. THERE WAS NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL | FZP | ETHICON ENDO SURGERY, INC (CINCINNATI) | NA | C4F68D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |